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RC-REGULATORY COMPLIANCE-CSV-QA -Manager

EY
📍 Pune, Maharashtra, India 💼 Full-time 🕒 Posted June 23, 2026
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Job Description

The opportunity

We are seeking a highly skilled CSV & Scrum Delivery Manager with strong expertise in GxP system validation and Agile delivery activities. The ideal candidate will ensure compliance with global regulations (FDA, EMA, MHRA), support cross‑functional teams, and drive the implementation and maintenance of validated systems across the pharmaceutical lifecycle, including Veeva Vault Quality, Clinical, and RIM. This role also involves client engagement, process optimization, and enabling operational excellence within regulated Agile environments.

Your key responsibilities

  • Lead validation activities for GxP and non GxP systems using a risk‑based approach aligned with GAMP 5 and SDLC principles.

  • Perform software classification, IT risk assessments, and define mitigation strategies.

  • Conduct gap assessments and remediation for legacy or non‑compliant systems.

  • Author and review core validation delive...

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    Job Details

    • Location Pune, Maharashtra
    • Job Type Full-time
    • Category Business Operations Specialists
    • Posted Date June 23, 2026
    • Application Deadline August 02, 2026